Work

Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products

Year: 2025

Type: article

Abstract: Considerable attention has been paid to the utilisation of real-world data throughout the lifecycle of pharmaceuticals, medical devices, and regenerative products. In Japan, regulatory initiatives have been implemented to promote the utilisation of real-world data and evidence for regulatory decision-making, especially focusing on the use of disease registries. In this brief article, we outline regulatory initiatives, summarise the current status of registry utilisation in Japanese regulatory settings, and offer points to consider and perspectives on registry utilisation for stakeholder collaboration.

Source: Journal of Pharmaceutical Policy and Practice

DOI: 10.1080/20523211.2025.2523935

Authors: Chieko Ishiguro, Yasutomo Teshima, Harumasa Nakamura

Institutions: National Center of Neurology and Psychiatry, National Center Hospital of Neurology and Psychiatry

Language: English

Topic: Healthcare Regulation

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,390